Genetics of Appendix Cancer: The GAP Study
| Registry | NCT05734430, acronym GAP |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 700 (Estimated) |
| Sponsor | Andreana Holowatyj, PhD, MSCI (Other) |
| Conditions | Appendix Cancer, Appendiceal Cancer, Appendiceal Neoplasms, Appendiceal Mucinous Neoplasm, Appendiceal Adenocarcinoma, Appendiceal Carcinoid Tumor, Appendiceal Neoplasm Malignant Secondary, Appendix Adenocarcinoma, Appendix Mucinous Neoplasm, Appendix Tumor, Appendix Cancer Metastatic, Appendix NET, Low-Grade Appendix Mucinous Neoplasm, High Grade Appendix Mucinous Neoplasm, High Grade Appendix Mucinous Adenocarcinoma |
| Interventions | Genetic profiling, Retrospective tissue procurement (Genetic, other) |
| Dates | start 2022-11-11, primary completion 2032-11-01 (estimated), completion 2034-11-01 (estimated), first posted 2023-02-21, last updated 2025-04-18 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Appendix Cancer All trials for Appendiceal Cancer All trials of Genetic profiling All trials of Retrospective tissue procurement
The GAP Study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix/appendiceal cancer who are ages 18+ years.
The Genetics of Appendix Cancer (GAP) Study aims to analyze hereditary factors, tumor characteristics and clinical features/outcomes among adults diagnosed with appendix cancer and their biological parents. Patients are recruited at any time after a diagnosis of appendix cancer and followed for up to 6 years after study enrollment. This cohort is enriched by robust biospecimens and data collections.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| GAP Social | Genetic: Genetic profiling; Other: Retrospective tissue procurement | Individuals ages 18+ years with an appendix cancer diagnosis in the United States. | |
| GAP Vanderbilt | Genetic: Genetic profiling; Other: Retrospective tissue procurement | Individuals ages 18+ years with an appendix cancer diagnosis seen at Vanderbilt. | |
| GAP Parent | Genetic: Genetic profiling | Biological parents of active GAP (Social and Vanderbilt) Study participants. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: GAP Social * Known diagnosis of appendix cancer in the United States * Mentally and physically able to consent and participate in the study GAP Vanderbilt * Known diagnosis of appendix cancer * Diagnosed by and/or consulting with a physician/clinical provider participating in the GAP Study * Mentally and physically able to consent and participate in the study GAP Parent * Biological parents (mother and/or father) of individuals actively participating in the GAP Study * Residing in the United States * Mentally and physically able to consent and participate in the study Exclusion Criteria: * Women pregnant at the time of consent * Prisoners * Unable to provide informed consent * Unable to read, write, or complete questionnaires in English
| Facility | City | Country | Status |
|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee | United States | Recruiting |